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FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children
Date:11/4/2008

short stature associated with Turner Syndrome, treatment of children with growth failure due to inadequate secretion of endogenous growth hormone, and treatment of short stature in children born SGA with no catch-up growth by age 2. It is also indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

1) Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

2) Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Important Safety Information

Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.

Norditropin(R) (somatropin [rDNA origin] injection) is used to treat children with growth failure caused by very low or no production of growth hormone. It is also used to treat adults who do not make enough growth hormone.

Do not use Norditropin(R) if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.

Children should not use Norditropin(R) if they have any of the following conditions: closed epiphyses (closed bone growth plates
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SOURCE Novo Nordisk
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